A recent article in The American Journal of Managed Care (AJMC) heralds the approval of a third CAR T-cell therapy, called Tecartus.
Kite Pharma’s cell-based gene therapy is the first to treat adult patients diagnosed with mantle cell lymphoma (MCL) that has relapsed or is resistant to treatment.
MCL, a type of non-Hodgkin lymphoma, affects the lymphatic system which is associated with the immune system. It is an aggressive cancer that generally affects men sixty and older.
The cancer cells, in this case, B-cells, are found in an area called the mantle zone. Intensive therapy is required as usually by the time it is diagnosed it has begun to progress rapidly.
Tecartus (brexucabtagene autoleucel) will be prepared in the same manner as the two previous therapies. The patient’s T-cells are collected then modified by including a gene that assists in targeting and killing lymphoma cells. The patient is then infused with the engineered T-cells.
About the ZUMA-2 Trial
Sixty adult patients with refractory or relapsed MCL participated in the multicenter trial and were monitored for six months following their initial disease response.
After treatment, sixty-two percent of patients were in complete remission. An overall response rate of eighty-seven percent was reported.
Dr. Michael Wang of MD Anderson, the trial’s lead investigator, commented that with Tecartus therapy, patients now have an opportunity for a durable remission.
About Cytokine Release Syndrome
Tecartus is Kite’s second FDA approved CAR T-cell treatment. Both the first therapy, Yescarta, and newly-approved Tescartus will undergo Mitigation Strategy (minimizing the impact) and Risk Evaluation (analyzing future impact) as a result of toxicities from cytokine release syndrome (CRS) and neurotoxicity.
CRS, an inflammatory response, can be set off by many factors such as a particular drug or by infections. The CRS or cytokine storm is of special interest. It is responsible for severe and often fatal adverse events in connection with these new therapies due to extreme T-cell stimulation.
The FDA Designations
The FDA breakthrough therapy and priority review were awarded through the Agency’s accelerated approval program. Tecartus was also granted orphan drug status. The purpose of the orphan drug designation is to encourage the development of new drugs for rare diseases.
The majority of lymphomas are not inherited. They occur when there is damage to the DNA in certain cells of the body (somatic DNA damage). Researchers and patients are looking forward to additional trials for mantle cell lymphoma.